A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

摘要: The primary purpose of method validation is to demonstrate that the fit for its intended use. Traditionally, an analytical deemed valid if performance characteristics such as accuracy and precision are shown meet prespecified acceptance criteria. However, these criteria not directly related method9s purpose, which usually a gurantee high percentage test results future samples will be close their true values. Alternate “fit purpose” based on concept total error have been increasingly used. Such allow assessing validity, taking into account relationship between precision. Although several statistical methods proposed in literature hypothesis, majority designed protect risk accepting unsuitable methods, thus having potential cause uncontrolled consumer9s risk. In this paper, we propose generalized pivotal quantity inference. Through simulation studies, compared five existing approaches. show both new β-content tolerance interval with confidence level 90%, hereafter referred (0.9) method, control Type I risk, while other do not. It further demonstrated less conservative than when biased, whereas it more unbiased. Therefore, selection either or depends method. also has better asymptotic properties all current methods. LAY ABSTRACT: Analytical often used ensure safety, efficacy, quality medicinal products. According government regulations regulatory guidelines, need validated through well-designed studies minimize This article describes novel validation, provides protection